Senior Quality Engineer - MedTech CAPA & RCA Lead

GForce Life Sciences; Redmond; On-site; AUD 90,000 - 120,000; Full time

Job summary

GForce Life Sciences is seeking a Quality Engineer to support manufacturing operations and supplier quality activities. The role emphasizes investigating non-conformances, driving root cause analysis and CAPAs, and aiding process improvements and validation efforts.

The ideal candidate has strong manufacturing quality experience, excellent problem-solving skills, and the ability to lead cross-functional teams in a fast-paced, regulated environment.

Qualifications

• Bachelor's degree in Engineering or related scientific discipline.
• 3+ years of Quality Engineering or related quality experience.
• Strong RCA and problem-solving experience; formal RCA preferred.
• Experience with manufacturing quality and cross-functional teamwork.
• Experience with process and equipment validation and reviewing validation documentation.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong communication to lead discussions and influence stakeholders.
• Experience in regulated industry; medical device or aerospace preferred.
• Familiarity with TrackWise, MasterControl, and SAP is beneficial.
• Knowledge of PPAP, DFMEA/PFMEA, Control Plans, and Process Flow Diagrams is a plus.

Responsibilities

• Partner with Operations, Engineering, Regulatory, Compliance and suppliers to maintain product and process quality.
• Own and manage non-conformances (NCs) and CAPAs, ensuring timely investigation, resolution, and closure within TrackWise.
• Lead root cause investigations and cross-functional problem-solving to address issues.
• Investigate and disposition non-conforming products; support MRB activities and containment actions.
• Support manufacturing-related complaint investigations and product field actions.
• Manage supplier quality activities, including SCARs, SICRs, and supplier changes.
• Lead and support PPAP activities related to supplier changes.
• Support manufacturing transfers and identify supplier part certification opportunities.
• Participate in process improvements, change management, and development of manufacturing/distribution processes.
• Review quality documentation, validation protocols/reports, and MSA activities.
• Monitor quality KPIs, analyze trends, and recommend actions to improve quality.

Skills

Root cause analysis

Problem solving

Cross-functional teamwork

Communication skills

Time management

Detail oriented

Education

Bachelor's degree in Engineering

Tools

TrackWise

MasterControl

SAP

Job description

GForce Life Sciences is seeking a Quality Engineer to support manufacturing operations and supplier quality activities. The role emphasizes investigating non-conformances, driving root cause analysis and CAPAs, and aiding process improvements and validation efforts.

The ideal candidate has strong manufacturing quality experience, excellent problem-solving skills, and the ability to lead cross-functional teams in a fast-paced, regulated environment.